CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) is an FDA 510(k)-cleared medical device (K925524) manufactured by Cardio Metrics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 1993. Regulation: 8.